Kornimate/medical-research-clean huggingface dataset:
fatigue, sleep disorders and endocrine abnormalities in tbi patients

Conditions: Traumatic Brain Injury

Summary: this study will test if patients with moderate to severe traumatic brain injuries also have endocrine abnormalities, examine any existing relationships among fatigue, depression and endocrine abnormalities, and the relationship between endocrine abnormalities, quality of life, and community integration.


Eligibility criteria:
inclusion criteria: * having moderate to severe tbi at least 3 months prior to enrollment. this can be demonstrated by a history of loss of consciousness, amnesia or another neurologic deficit after brain injury * be between the ages of 18 and 70 years exclusion criteria: * history of prior tbi, stroke, seizures, severe psychiatric disturbances (i.e., those known to influence memory performance, such as schizophrenia, bipolar disorder), or drug abuse will be excluded. * pregnant, nursing, or planning pregnancy during the study period. * dementia * other neurological conditions which are associated with aging and known to cause fatigue (e.g. parkinson's disease)
dynamic humeral centering in impingement syndrome

Conditions: Degenerative Rotator Cuff Disease With Impingement Syndrome

Summary: the purpose of this study is to determine wether dynamic humeral centering is effective in patients with impingement syndrome of the shoulder

clinical trial with randomization for treatment and physiotherapist

Eligibility criteria:
inclusion criteria: * age \> 30 years * pain duration \> 1 month * presence of at least 2 positive impingement test results from neer, yocum and hawkins testing * total constant score \< 80. exclusion criteria: concerning the shoulder * stiffness * anteroposterior instability * tendinous calcification * corticosteroid injection within the previous 30 days * previous surgery * humeral fracture * inflammatory joint disease * neoplastic disorders

Keywords: degenerative rotator cuff disease impingement syndrome dynamic humeral centering randomized clinical trial
correlation of campbell score with suicidal ideation

Conditions: Suicidal Ideation

Summary: the campbell score is a blood based means of assessing molecules believed to be associated with suicidal ideation and in some cases successful suicide. the current clinical trial will assess the campbell score in 3 groups: group 1: 10 patients with no personal or family psychiatric history and no suicide attempts. group 2: 10 patients with suicidal ideation (hamilton depression rating scale suicide item \>2) and reported low acquired capability for suicide (acquired capability for suicide scale \<20). group 3: 10 patients with suicidal ideation (hamilton depression rating scale suicide item \>2) and reported high acquired capability for suicide (acquired capability for suicide scale \>60). the goal of the study is to confirm efficacy of campbell score in identifying patients with high suicidal ideation potential.


Eligibility criteria:
inclusion criteria: * capability of giving informed consent * agree to abide by the study protocol and its restrictions and be able to complete all aspects of the study. * be diagnosed with suicide ideation/attempts/gestures exclusion criteria: - not currently pregnant or lactating (due to potential confounding of brain activity as a result of differing hormone levels)

Keywords: interleukin-6, suicidal ideation, immunology
effect of the plan cuidarte on the caregiving competence of people with heart failure

Conditions: Heart Failure; Caregiver Burden; Discharge Plan; Care Transitions; Nursing

Summary: according to the world health organization (who), by 2021 cardiovascular diseases (cvd) will be a public health problem, among them heart failure (hf), since this is a chronic disease, patients should be competent in their care. despite the above, according to research conducted in colombia, 59.7% of people with chronic noncommunicable diseases (ncds) have a level of care competence considered not optimal; patients report not having sufficient knowledge of the disease or experience feelings of lack of tools for the management of symptoms and the challenges of post-hospitalization. the objective of the research is to determine the effect of the plan cuidarte on the caregiving competence of people with hf methodology: pre-posttest randomized clinical trial, with blinding of the participants, where the intervention "plan cuidarte" is applied and the initial and subsequent caregiving competence is evaluated in the comparison group and in the intervention group for pretest - posttest and between-group comparisons.

eligibility criteria: inclusion criteria * patients over 18 years of age with a diagnosis of hf. * patients with hf who are hemodynamically stable. * patients with spmsq - pferffer of 0 - 4 errors or 5 errors, patient who has not received primary education. * patient with a pulses of 6 to 11 exclusion criteria * patients with heart failure with heart transplantation scheduled in the next 6 months. * patients requiring transfer to an intensive or intermediate care unit. outcome measures: * primary: caring competence. * secondary: satisfaction with care

Eligibility criteria:
inclusion criteria: * patients over 18 years of age who are hospitalized and admitted to the institution with a diagnosis of hf decompensation with a time of diagnosis greater than 6 months. * patients who are hemodynamically stable, without alteration of the state of consciousness. exclusion criteria: * hf patients who are hospitalized for cardiac transplantation, * who are under palliative management or who, at the time of discharge, have a formal * who have a designated formal caregiver or are discharged to an institution other than home.
lot-to-lot consistency of tritanrix™-hepb/hib-menac & its non-inferiority vs tritanrix™-hepb/hiberix™ in infants

Conditions: Tetanus; Hepatitis B; Haemophilus Influenzae Type b; Whole Cell Pertussis; Diphtheria

Summary: the primary purpose of this study is to demonstrate the lot-to-lot consistency of 3 production lots of gsk biologicals' hib-menac (haemophilus influenzae type b and meningococcal serogroups a and c) vaccine when reconstituted with tritanrix™-hepb (diphtheria, tetanus, pertussis, and hepatitis b) vaccine and administered as a single injection.

the study is double blind. however the active control vaccine tritanrix™-hepb/hiberix™ will be administered in a single-blind manner. blood samples will be collected for immunogenicity analyses. gsk biologicals' opv vaccine will be administered concomitantly with the study vaccines at 2, 4 and 6 months of age according to local country regulation. the study will last approximately 5 months per subject

Eligibility criteria:
inclusion criteria: * healthy male or female, between, and including, 56 and 83 days of age. * born after a gestation period between 36 and 42 weeks * birth dose of hepatitis b vaccine within the first 72 hours of life exclusion criteria: * planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before the first dose of study vaccine, or planned administration during the study period. * bacille calmette-guérin (bcg) vaccine received after the first 2 weeks of life. * history of or previous vaccination against or known exposure since birth to diphtheria, tetanus, pertussis, hepatitis b, haemophilus influenzae type b and/or meningococcal disease. * any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (hiv) infection * a family history of congenital or hereditary immunodeficiency * history of any neurologic disorders or seizures * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine

Keywords: haemophilus influenzae type b diphtheria tetanus prophylaxis diphtheria pertussis hepatitis b meningococcal serogroups a & c diseases
reduced immunosuppressive therapy with or without donor white blood cells in treating patients with lymphoproliferative disease after organ transplantation

Conditions: Lymphoproliferative Disorder

Summary: rationale: some types of lymphoproliferative disease are associated with epstein-barr virus. combining reduced immunosuppressive therapy with donor white blood cells that have been treated in the laboratory to kill cells infected with epstein-barr virus may be an effective treatment for lymphoproliferative disease. purpose: randomized phase iii trial to compare the effectiveness of reducing immunosuppressive therapy with or without donor white blood cells in treating patients who have epstein-barr virus-associated lymphoproliferative disease after organ transplantation.

objectives: * determine the efficacy of treatment with partially hla-matched allogeneic cytotoxic t cells and reduction of immunosuppression, in terms of survival rate and time to remission in patients with epstein-barr virus-associated b-cell lymphoproliferative disease after solid organ transplantation. outline: this is a randomized, multicenter study. patients are stratified according to transplanted organ type and transplant center. patients are randomized to 1 of 2 treatment arms. * arm i: patients undergo sliding-scale reduction of immunosuppressive drugs from 1 of 5 regimens at physician's discretion. patients then receive partially hla-matched allogeneic cytotoxic t cells iv over 5 minutes once weekly for a total of 4 weeks. * arm ii: patients undergo reduction of immunosuppression as in arm i alone. patients are followed monthly for 6 months and then every 3 months for 2 years. projected accrual: a total of 50 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of post-transplant lymphoproliferative disease (ptld) after solid organ (heart, heart/lung, liver, liver/gut, pancreas, or kidney) transplantation * epstein-barr virus-positive tumor * newly diagnosed disease * measurable disease by clinical methods or radiography * must have partially matched donor cytotoxic t cells (ctl) available * no known panel reactivity to any of the hla types of ctl available for therapy patient characteristics: age: * any age performance status: * karnofsky 20-100% life expectancy: * not specified hematopoietic: * not specified hepatic: * not specified renal: * not specified other: * not pregnant prior concurrent therapy: biologic therapy: * not specified chemotherapy: * not specified endocrine therapy: * not specified radiotherapy: * not specified surgery: * not specified other: * no prior therapy for ptld * no concurrent antiviral drugs (e.g., acyclovir or ganciclovir) for ptld

Keywords: post-transplant lymphoproliferative disorder
efficacy of distilled water versus mitomycin c on preventing recurrences of bladder cancer after transurethral resection

Conditions: Recurrent Superficial Bladder Cancer; Distilled Water

Summary: the purpose of this study is to compare and evaluate the efficacy of distilled water vs mitomycin c on preventing the recurrences of intermediate risk group recurrent superficial bladder cancer administered as a single dose immediate instillation after complete transurethral resection(tur) of the tumor.

we plan to administer 200ml of distilled water as a single peroperative instillation and block the catheter for 2 hours to our eligible recurrent superficial bladder cancer patients who were in our follow-up schedule since 2002. we plan to look over the histories of the same patients in terms of the pathologies, recurrence patterns, the presence of peroperative intracavitary therapy after their previous turs for recurrences. so we shall compare the effectiveness of mmc and distilled water on reducing the recurrences over the same patient pool. the patients will be scheduled for a follow-up program after tur as; * cystoscopy * urine cytology * bladder wash cytology for the probability of recurrence for 2 years to see if there is any difference in the recurrence patterns after instillation with distilled water vs mmc.

Eligibility criteria:
inclusion criteria: * pathologic finding of superficial bladder cancer within the intermediate risk group * recurred after 6 months from the primary tumor * those patients who were included in our follow-up program since 2002 and whose records could be obtained. exclusion criteria: * carcinoma in situ * any form of intracavitary maintenance therapy * any form of bladder cancer other than transitional cell type

Keywords: distilled water recurrent bladder mitomycin
a study of ym155 plus docetaxel in subjects with stage iii (unresectable) or stage iv melanoma

Conditions: Melanoma

Summary: the purpose of the study is to evaluate survival, response rate, safety and tolerability of ym155 given in combination with docetaxel in subjects with stage iii (unresectable) and stage iv melanoma.

all subjects will receive ym155 and docetaxel given in a 21-day cycle. the docetaxel dose will be established based on the findings of the lead-in portion of the study (part 1). once the docetaxel dose is established, part 2 enrollment will begin. part 1: part 1 is a lead-in stage that will confirm if ym155 can be safely administered in combination with docetaxel at a specified dose. part 2: subjects enrolled in part 2 will receive ym155 and docetaxel at the dose established during part 1.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed stage iii (unresectable) or stage iv melanoma * no prior systemic treatment or cytotoxic chemotherapy for advanced melanoma (stage iii or stage iv) * if the subject is female, she must be non-pregnant and non-lactating at the baseline visit. all sexually active males and females of childbearing potential must agree to use an adequate method of contraception throughout the study period * eastern cooperative oncology group (ecog) performance status \</= 1 * life expectancy \> 12 weeks * at least one measurable target lesion according to response evaluation criteria in solid tumors ({recist} version 1.1) * subjects with a previous history of non-melanoma malignancy must have undergone curative therapy for all prior malignancies and be considered disease free for at least 5 years exclusion criteria: * major surgery within 21 days of the baseline visit * presence or history of brain metastases * primary ocular, choroidal or mucosal melanoma * known history of positive test for hepatitis b surface antigen (hsbag) or hepatitis c antibody or history of positive test for human immunodeficiency virus (hiv) * hypersensitivity to docetaxel or polysorbate 80 * neuropathy greater than or equal to grade 2 at baseline visit * the subject has been previously treated with ym155 * inadequate marrow, hepatic, and/or renal functions

Keywords: melanoma, stage iii melanoma, stage iv ym 155 metastatic melanoma
comparison of clarus and optos ultrawide field imaging systems for inherited retinal disease

Conditions: Retinal Disease

Summary: the goal of this research study is to compare two ultrawide field cameras to the gold standard imaging system to evaluate the back of the eye. the main question it aims to answer is the same results and information can be acquired from all of the cameras for evaluating and monitoring inherited retinal diseases (irds). participants will: * undergo pupillary dilation * have photographs taken of the inside of the eyes using three different cameras


Eligibility criteria:
inclusion criteria: * participants 18 years and older with a clinical and/ or genetic diagnosis of ird recruited either from the clinic and/or the inherited ocular disease registry to participate in this trial * participants that are willing to participate as evidenced by signing the written informed consent exclusion criteria: * presence of ocular conditions other than an ird which may affect the quality of ocular imaging including but not limited to advanced cataracts, corneal disorders, nystagmus, vitreous hemorrhage, or poor dilation * presence of ocular conditions other than an ird which may affect interpretation of retinal imagining including but not limited to epiretinal membrane, choroidal neovascular membrane, or macular scarring * patients with advanced irds who are unable to fixate for imaging * patients unable to tolerate ocular imaging * patients who do not wish to participate
daratumumab, pomalidomide, and dexamethasone (dpd) in relapsed/refractory light chain amyloidosis patients previously exposed to daratumumab

Conditions: Amyloid; AL Amyloidosis; Refractory AL Amyloidosis

Summary: this study will test the hypothesis that in patients with previous daratumumab exposure, combination therapy of daratumumab, pomalidomide, and dexamethasone (dpd) will yield higher complete remission (cr) rates in relapsed/refractory amyloidosis than historical pomalidomide/dexamethasone treatment.


Eligibility criteria:
inclusion criteria: * diagnosis of primary al amyloidosis of tissue * relapsed and/or refractory al amyloidosis * has received daratumumab or faspro in any prior line of therapy * prior pomalidomide exposure allowed if ≥ pr achieved and no disease progression occurred within 60 days of last dose received * measurable disease * able to give voluntary written consent * eastern cooperative oncology group performance status and/or other performance status 0, 1, or 2. * absolute neutrophil count (anc) ≥ 1,000/mm3 and platelet count ≥ 75,000/mm3. * total bilirubin ≤ 1.5 × the upper limit of the normal range (uln) (total bilirubin ≥ 1.5 x uln is acceptable if bilirubin is fractionated and direct bilirubin \<35%) * alanine aminotransferase (alt) and aspartate aminotransferase (ast) ≤ 3 × uln. * egfr ≥ 20 ml/min/1.73 m2 (as calculated by modified diet in renal disease (mdrd) formula) exclusion criteria: * non-al amyloidosis * clinically overt myeloma * prior exposure to non-daratumumab anti-cd38 monoclonal antibodies. * clinically significant cardiac disease * severe obstructive airway disease * female patients who are lactating or have a positive serum pregnancy test during the screening period * planned high-dose chemotherapy and autologous stem cell transplantation within 6, 28-day treatment cycles after starting on treatment. * failure to have fully recovered (ie, ≤ grade 1 toxicity) from the reversible effects of prior chemotherapy. * major surgery within 14 days before enrollment. * radiotherapy within 14 days before enrollment. * infection requiring systemic intravenous antibiotic therapy or other serious infection within 14 days before study enrollment. systemic treatment, within 14 days before the first dose, with strong cyp3a inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital, see appendix 11.7), or use of ginkgo biloba or st. john's wort. * positive for human immunodeficiency virus (hiv), hepatitis b, and hepatitis c * diagnosed or treated for another malignancy within 2 years before study enrollment or previously diagnosed with another malignancy and have any evidence of residual disease. patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
transanal haemorrhoidal dearterialisation versus stapler haemorrhoidopexy

Conditions: Haemorrhoids

Summary: the aim of the present study was to compare the results of transanal haemorrhoidal dearterialisation and stapler haemorrhopidopexy in the treatment of grade iii and iv haemorrhoids with a long-term follow-up.


Eligibility criteria:
inclusion criteria: * grade iii and iv hemorrhoids requiring hemorrhoidectomy. exclusion criteria: * first and second degree hemorrhoids * patients with firm and fibrotic external irreducible haemorrhoids * thrombosed hemorrhoids; recurrent hemorrhoids after previous surgical treatment * history of inflammatory bowel disease; history of colon, rectal or anal cancer * inability to give informed consent * age \< 18 years * pregnant women.
implementation of academic detailing interventions on prescribing of antimicrobial drugs in primary health care

Conditions: Upper Respiratory Tract Infections; Acute Respiratory Tract Infection; Viral Infection

Summary: world increase in mortality from consequences of antimicrobial resistance (amr) represents a significant public health problem. irrational prescribing of antimicrobial drugs (amd) in general population is one of the main causes of development amr. this is also contributed by fact that up to 90% of total antimicrobial consumption in europe is related to the general population. problem of amr has been recognized by world health organization and council of european union, which support the establishment of the antimicrobial stewardship team (a-team). a-team provides co-ordinated interventions that promote rational use of amd. to date, no study has been carried out in which a-team from hospital environment goes to primary health care for the purpose of rationalization prescribing of amd by primary health care practitioners. project for implementation of hospital a-team in primary health care in koprivnica-križevci county was initiated using academic detailing method aimed at rationalization of the consumption of amd.


Eligibility criteria:
inclusion criteria: * all primary care physicians in koprivnica križevci county that agree to participate in the study exclusion criteria: * primary care physicians outside koprivnica križevci county

Keywords: antimicrobial resistance hospital a-team academic detailing intervention antimicrobial prescribing primary care
tool for sibling and children of someone with suicidal thoughts

Conditions: Suicide

Summary: this study aims to investigate to what extent a website developed for siblings and children (16-25 years old) of someone with suicidal thoughts and/or behaviors is effective in improving perceived pressure, knowledge, attitudes, self-confidence and hopelessness. moreover, it aims to examine how participants evaluate the website.


Eligibility criteria:
inclusion criteria: * siblings and children of someone who has suicidal thoughts and/or behavior * 16-25 years old * have access to internet * speak dutch exclusion criteria: * /
four week safety and efficacy study with a topical gel to treat common warts in pediatric subjects

Conditions: Warts

Summary: the primary purpose of this study is to evaluate the effectiveness in pediatric subjects of three different strengths of resiquimod gel applied to common wart(s) three times a week for four weeks. a second purpose is to evaluate the safety of the drug.


Eligibility criteria:
inclusion criteria: * diagnosis of common warts * ages between 3 to 11 exclusion criteria: * other types of wart(s), ie. plantar * currently participating in another clinical study * chronic viral hepatitis b or c

Keywords: common wart(s) pediatric wart(s) children 3m pharmaceuticals resiquimod